In general, the registration will take between 3 to 6 months. However, it all depends on the classification of your medical device. Class 1A, it may take 3 – 4 months, class 2B and 2C may take 4-5 months and class 3D may take up to 6 months

Currently, Indonesia holds a four-grade risk evaluation system as follows:

• Category A (low risk) – if mishandled or not used properly, medical device is not harmful to humans.
• Category B (low to moderate risk) – if mishandled or not used properly, medical device can have some serious effects but will not be considered as a serious accident to humans.
• Category C (moderate to high risk) – if mishandled or not used properly, medical device can have very serious effects but will not be considered as a serious accident to humans.

• Category D (high risk) – if mishandled or not used properly, medical device can have some serious effects and will be considered as a serious accident to humans.